Arrayit Microarray product line has been recently submitted to the FDA and is now pending approval

1-2-18: Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance https://www.fda.gov

“our comprehensive Allergy Program Offering, Including Allergy Labs of America, Allergy-Pro and the New Finger Stick Blood Drop Allergy Cards. The bulk of the call will also be discussing 2 new Lab Partners that we have recently added to our network.”

The services on this website are provided by ARRAYIT CORPORATION, a Nevada corporation (“Arrayit”) and ALLERGYGO, LLC, a Texas limited liability company (“AllergyGo”). Arrayit is in the business of developing and manufacturing certain proprietary life science technologies for disease prevention and treatment, specifically including advanced blood card technology with IgE microarray testing for allergens (“Tests”), and AllergyGo is in the business of marketing and distributing allergy testing products.

Arrayit recently completed an allergy testing pilot program for a top retail chain, established a nationwide network of 1,700 allergy sales professionals, met with top officials at the United States Food and Drug Administration (FDA) regarding FDA approval of a major product line, reported the sale of clinical instrumentation to the FDA, signed allergy testing contracts with a consortium of 178 medical clinics and received approval for in-store promotions by a major retailer. Arrayit’s new therapeutics partners provide a seamless solution to doctors who diagnose and treat the more than 50 million Americans reporting allergic symptoms annually.

The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.

Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.

1-3-18 Arrayit advanced microarray technology to be incorporated into a clinical trial by a major pharmaceutical giant in a development that could significantly increase revenues and earnings in 2018 arrayit.com/Products/products.html

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